A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users

Trial Profile

A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Aug 2014

At a glance

  • Drugs Hydrocodone/paracetamol (Primary) ; Hydrocodone; Paracetamol
  • Indications Pain
  • Focus Pharmacodynamics; Registrational
  • Most Recent Events

    • 26 Aug 2013 Primary endpoint 'Drug cravings' (subject like/dislike scores) has not been met according to an Acura Pharmaceuticals media release.
    • 26 Aug 2013 Primary endpoint 'Drug-cravings' has not been met.
    • 26 Aug 2013 Acura Pharmaceuticals will further evaluate trial results with plans to meet with the US FDA for discussion. The NDA submission will likely be delayed as a consequence of failure to demonstrate statistical significance for the primary endpoint.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top